First race-based drug receives FDA approval

Some advise looking beyond race and determining the underlying causes for heart failure when deciding whether to add BiDil to conventional treatments.

By Susan J. Landers, AMNews staff. July 11, 2005.

Washington -- The heart failure drug BiDil has become a flashpoint for debate and discussion.

Now, it will likely become even more of a hot topic because this fixed-dose, single pill, a combination of isosorbide dinitrate and hydralazine, shown in clinical trials to be helpful in treating heart failure in African-American patients, gained Food and Drug Administration approval on June 23.

The trick for physicians will be to determine when it is indicated. And the key questions: Is it just for African-American patients? Or perhaps it's helpful for all patients who share an as-yet-unrecognized genetic trait?

An FDA advisory committee voted unanimously on June 17 in favor of agency approval after sifting through the evidence. The FDA approval came just days later.

The majority of committee members also agreed with BiDil's manufacturer, NitroMed of Lexington, Mass., that the medication label should indicate it is intended for black patients.

Nearly 5 million Americans are living with heart failure, and 550,000 new cases are diagnosed each year, according to the American Heart Assn. The condition is particularly common among black patients, affecting about 3% of all adult African-Americans.

African-American patients also develop symptoms of heart failure at an earlier age than do patients of other races, according to the heart association, possibly because they are more likely to have hypertension and diabetes than others and because they more frequently exhibit sodium retention, ventricular hypertrophy and vascular injury. Lack of access to quality health care may also play a role. However, coronary artery disease is less common in blacks with heart failure than in whites with this condition.